| Primary Device ID | 00814695022588 |
| NIH Device Record Key | c07bb4b6-a43b-4590-96d8-3e1f97ddb2d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LABScan3D™ |
| Version Model Number | N/A |
| Catalog Number | LABSCNXS4 |
| Company DUNS | 118289289 |
| Company Name | ONE LAMBDA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800.822.8824 |
| techsuppoort@onelambda.com | |
| Phone | 800.822.8824 |
| techsuppoort@onelambda.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814695022588 [Primary] |
| NSU | Instrumentation For Clinical Multiplex Test Systems |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-31 |
| 00812117015484 - PE-Conjugated Streptavidin | 2020-06-12 For use in the detection of biotinylated proteins and nucleic acids in biotinylated proteins and nucleic acids in LABType™ SSO |
| 00812117010199 - LABScreen™ Single Antigen HLA Class I ExPlex | 2020-06-11 LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology |
| 00812117014654 - LABScreen™ Single Antigen HLA Class II ExPlex | 2020-06-11 LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology |
| 00814695022496 - UniMatch™ Plus Software | 2019-01-23 UniMatch PLUS Software analyzes the reaction patterns of UniTray™ and AllSet+™ Gold kits for the determination of Human Leuk |
| 00812117015255 - Adsorb Out | 2018-07-16 To reduce high background that is caused by nonspecific binding of materials in human sera to the latex beads used in flow antib |
| 00814695024452 - Micro SSP™ Gel System - 108 Wells | 2018-07-16 The Micro SSP Gel Box System is a compact gel box for electrophoresis. |
| 00812117015873 - Fluorobeads™ T Lymphocyte – 25 Isolations | 2018-07-02 FluoroBeads-T provide a simple procedure for the isolation of T lymphocytes for use in microcytotoxicity assays using fluorescen |
| 00812117015880 - Fluorobeads™ B Lymphocyte – 25 Isolations | 2018-07-02 FluoroBeads-B provide a simple procedure for the isolation of B lymphocytes for use in HLA Class II typing assays using fluoresc |